Associate Director​/Director, Biostatistics

Overview

Concord, MA

About This Role: We are seeking an experienced Associate Director/ Director of Biostatistics to support strategic and operational biostatistical activities across post-marketing programs. This hands-on role will provide scientific and statistical leadership to support Global Medical Affairs evidence generation for observational studies, and real-world evidence generation, with a strong focus on Medical Affairs, Market Access, and pharmacoepidemiology. This role ensures robust data interpretation, compliance with regulatory standards, and strategic insights for medical decision-making.

• Design and execute statistical analyses for observational studies, registries, and post-marketing research.
• Develop statistical analysis plans (SAPs) for real-world data and medical affairs projects.
• Apply advanced methods (e.g., survival analysis, propensity score matching, mixed models) to assess treatment patterns, outcomes, and disease burden.
• Lead epidemiological assessments of disease prevalence, incidence, and natural history.
• Support development of burden-of-illness and health economics models.
• Collaborate on protocol design for non-interventional studies and patient registries.
• Provide statistical input for scientific platforms, publications, and congress presentations.
• Interpret data for medical information responses, advisory boards, and educational materials.

You are a hands-on biostatistics leader with deep expertise in post-marketing and real-world evidence, translating complex observational data into clear, compliant insights that inform Medical Affairs and Market Access decision-making.

• Education:
  
  Ph.D. or M.S. in Biostatistics, Statistics, or related field.
• Minimum 7 years in biostatistics within the pharmaceutical or biotech industry.
• Proven leadership in post-marketing research.
• Strong background in Medical Affairs.
• Proficiency in SAS, R, and advanced statistical methodologies.
• Familiarity with real-world data sources and epidemiological study designs.
• Excellent communication and leadership abilities.
• Ability to influence and collaborate across global, matrixed teams.

• Experience in Market Access analytics preferred.
• Experience in pharmacoepidemiology preferred.

The base compensation range for this role is: $210,000-$250,000 annually. Compensation is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.